Development of a MID for the 1-minute Sit-to-stand Test | NCT02708719

Studies
Development of a MID for the 1-minute Sit-to-stand Test

NCT02708719

Sponsor

Schön Klinik Berchtesgadener Land

Status

Completed

Last Update Posted

Feb 15, 2018Actual

Enrollment

105Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Pulmonary rehabilitation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Mar 10, 2016

First Submission Date that Met QC Criteria

Mar 10, 2016

First Posted Date

Mar 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2018

Last Update Posted Date

Feb 15, 2018Actual

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the minimal important difference (MID) for the 1-minute-sit-to-stand-test (STST) with an anchor-based method.

Detailed Description

In this study we develop the minimal important difference for the 1-minute sit-to-stand-test (STST) with an anchor-based method.

First step of this study is to find out the differences in the number of repetitions during 1-minute STST, 6-minute walk distance and health-related quality of life from pre to post inpatient pulmonary Rehabilitation program (3 weeks Duration) in the Schoen-Klinik Berchtesgadener Land.

In Addition, Balance tests on the Leonardo-Mechanograph will be performed and the Hospital Anxiety and Depression Scale (HADS) and Chronic Respiratory Questionnaire (CRQ) will be assessed.

For the second step we will use an anchor-based approach to estimate the MID of the STST. 6MWD and CRQ are used as anchors for which the MID has been established before.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary rehabilitation	Other	multimodal pulmonary Rehabilitation program (3 weeks Duration)	Procedure: Pulmonary rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehabilitation	Procedure	Inpatient pulmonary rehabilitation has a duration of 3 weeks. This multimodal program consists of exercise training, breathing therapy, medical council, education and psychological support.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MID of the 1-minute-STST	Change of maximum 1-minute sit-to-stand repititions	21 days

Secondary Outcomes

Measure	Description	Time Frame
6-minute-walk distance	Maximal walk distance reached in 6 minutes	21 days
CRQ Score	CRQ is a health-related Quality of life questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with COPD (GOLD-Stage II to IV)
Ability to stand-up and walk
written informed consent

Exclusion Criteria:

orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training
acute exacerbation
heart failure, acute coronary syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus Kenn, Prof. Dr.	Schoen Klinik BGL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Berchtesgardener Land		Schönau am Königssee	Bavaria	83471	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided